New incident report
Incident Report Number: 2017-4049
Registrant Reference Number: USA-BAYERBAH-2017-US0014918
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson Blvd
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
Domestic Animal
Country: UNITED STATES
Prov / State: UNKNOWN
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-144
Product Name: K9advantix II extra large dog
Other (specify)
Spot-onYes
Units: mL
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Labrador Retriever
1
Female
Unknown
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
>1 mo and <= 2mos / >1 mois et < = 2mois
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date in approximately 2016, a female, Retriever (Labrador, Black) canine, of unknown age, weight, and condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Extra Large Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. On an unknown date post product application, in 2016, the canine exhibited anemia. The canine was started on unknown medications; it is unknown if the canine was examined by a veterinarian. Approximately two months post onset of clinical signs, in 2016, the canine died. No necropsy was performed. The reason for the initial contact by owner was to discuss expiration of the product and not to report the death in this event. No further information expected. This case is closed.
Death
N - Unlikely Anaemia and further reported death are not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Very low level of information (age, medical history and time to onset unknown - necropsy not available) as the reason for the initial contact by owner was to discuss expiration of the product and not to report the death in this event. Other etiologies more probable. Even though time to onset unknown, occurrence of sign within window of allergic/anaphylactic reaction (within 1 day) unlikely, as would have been reported in close proximity. Considering all aspects, a product connection is deemed to be unlikely.